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Clinical Trials/NCT04138784
NCT04138784
Unknown
Not Applicable

Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women

Universidad de Granada0 sites38 target enrollmentDecember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Universidad de Granada
Enrollment
38
Primary Endpoint
Changes in Functionality
Last Updated
6 years ago

Overview

Brief Summary

Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.

Detailed Description

The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.

Registry
clinicaltrials.gov
Start Date
December 2019
End Date
March 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Assistant profressor

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of primary symptomatic KOA according to the criteria of the American College of Rheumatology
  • Women aged older than 65 years
  • Pain predominantly over the last 3 months
  • Kellgren and Lawrence score ≥2.

Exclusion Criteria

  • Ankle, hip or foot severe disorders
  • Chronic back pain
  • Alzheimer's disease, Parkinson's disease, motor neuron disorders.
  • Diabetes mellitus
  • Cardiac or respiratory insufficiency
  • Inability to understand the procedure

Outcomes

Primary Outcomes

Changes in Functionality

Time Frame: Baseline, 8 weeks, 3 months

Changes in Functionality is going to be assessed by the Western Ontario and McMaster Universities (WOMAC). Scores range from 0 to 96, with higher scores indicating greater disease severity.

Changes in Physical Performance

Time Frame: Baseline, 8 weeks, 3 months

Changes in Physical Performance is going to be assessed by The Timed up ad go. It involves a person standing from a 46-cm-high chair, walking 3 m, turning, walking back to the chair and sitting down.

Changes in Perceived Health Status

Time Frame: Baseline, 8 weeks, 3 months

Changes in Perceived Health Status is going to be assessed by the EuroQol-5D.It contains two sections, a descriptive section and a valuation section. The descriptive section is a health status classification instrument with the following five dimensions: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. In the second section, respondents are asked to value their overall health status on a visual analogue scale ranging from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state)

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